Surical Techniue - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes... ·...

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Surgical Technique 4.5 System This publication is not intended for distribution in the USA.

Transcript of Surical Techniue - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes... ·...

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Surgical Technique

4.5 System

This publication is not intended for distribution in the USA.

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EXPEDIUM® 4.5 Spine System 2

Features and Benefits 3

Surgical Technique

Extended Tandem Connector 4

Placement 5

Rod Rotation 7

Intra-Operative Compression and Distraction 8

Bridging Proximal and Distal Rods 9

Contents

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S U R G I C A L T E C H N I Q U E

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EXPEDIUM 4.5 SPInE SySTEM

“Larger deformities in smaller anatomies are

still one of the most challenging issues in

spinal surgery.”

Statements like this highlight a common sentiment

among spine surgeons engaged in the treatment

of small stature patients. Concerns over implant

profile and implant selection, along with the ability

to choose instrumentation based on patient size

and pathology are fairly common when treating

this patient group.

Seeking to eliminate these concerns, DePuy Spine

has developed a rod-hook-screw system

specifically designed for these smaller anatomies:

the EXPEDIUM 4.5 Spine System.

The new EXPEDIUM system exhibits the lowest

profile in our Thoracolumbar Portfolio, making it a

useful option for cases in which the surgeon is

challenged with implant protrusion and cosmetic

problems.

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4.5 System

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FEATUrES AnD bEnEFITS

Features benefits

Low implant profile • Decreases soft tissue disruption and may improve cosmesis

In-Line Technology• Appropriate implant option for specific patient anatomy,

indication, and surgeon’s preferred technique

Offset Technology• Appropriate implant option for specific patient anatomy,

indication, and surgeon’s preferred technique

Complete line of Hooks• Appropriate implant option for specific patient anatomy,

indication, and surgeon’s preferred technique

System includes Ti and SS and CoCr Rods• Appropriate implant option for specific patient anatomy,

indication, and surgeon’s preferred technique

Completely re-designed instruments

(NOT just downsized!)

• Provide the precision and tactile feel critical for procedures in smaller anatomies

Square Thread Set Screw, TOP NOTCH™, Reduction Tools • Secure closure mechanism, implant/instrument interface

Interconnectivity with other EXPEDIUM products• Offers the ability to create hybrid constructs and simplifies

revision cases

New design for the Extended Tandem Connector• Easier implantation and correction maneuvers

• More tissue friendly

• Stronger construct

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EXTEnDED TAnDEM ConnECTor

The device presented in this surgical technique is

indicated for skeletally mature spines and can be

used in a number of deformity correction

techniques such as rod rotation, segmental

correction, osteotomies or revisions, among others.

The selection of the correction technique and

anchors for the Extended Tandem Connector

construct is dependent on diagnosis and curve

type.

The most typical construct in which this device is

used consists of two Extended Tandem Connectors,

two dual diameter rods per connector (4.5-5.5

mm) and anchors above and below each

connector.

This surgical technique manual should be used in

conjunction with the EXPEDIUM Spine System

Surgical Technique.

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PLACEMEnT

Sizing and Locating the Extended Tandem

Connector in the Spine

• Locate the flattest portion of the spine in the

sagittal plane (generally around the Thoracolumbar

Junction) and choose the size of the Extended

Tandem Connector that will best fit the anatomy.

The length of the connector should not exceed the

length of the flat portion of the spine (Figure 1).

Note: It is better to place the Extended

Tandem Connector above L3, as the curvature

of the spine significantly increases in the

portion between the lumbar spine and the

sacrum.

• In the Coronal Plane, the Extended Tandem

Connector is located over the pedicles, between

the spinous process and the transverse processes

(Figure 2).

Note: Dual Diameter rods (4.5 mm to 5.5 mm)

must be used to build constructs with the

Extended Tandem Connector. The 5.5 mm

portion of the rod will connect with the

Extended Tandem Connector while the 4.5

mm portion of the rod will connect with the

anchors.

Anchor Insertion

• Prepare the sites for insertion of at least four

anchors in the proximal spine and four anchors in

the distal spine. These anchors are inserted in the

levels other than the ones chosen for the

connector (Figure 3).

Note: 4.0 mm diameter screws cannot be used

in an Extended Tandem Connector/Dual

Diameter rod construct.

Extended Tandem Connector 

FIGURE 1: Connector Placement Sagittal Plane

FIGURE 2: Connector Placement in the Coronal Plane

FIGURE 3: Connector Placement in the Coronal Plane

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rod Template & rod Contouring

• Place the Extended Tandem Connector at the

chosen site.

• To determine the length of the rods to be used

above and below the connector place the rod

template inside the proximal and distal anchors

and mark on the template where the ends of the

Tandem Connector lie and where the ends of the

4.5 mm portion of rods will be cut. Make an

additional mark on the template where the

centreline of the connector is.

• Remove the template from the anchors making

note which end is the proximal end.

• Place the 5.5 mm portion near the transition zone

of the proximal dual diameter rod up against the

mark that was made on the rod template that

signifies the proximal end of the connector.

• Cut the 4.5 mm portion of the rod at the mark on

the template that signifies the end of the proximal

4.5 rod. Cut the 5.5 mm portion of rod that

signifies the centreline of the connector minus 2.5

mm (allows space for the Tandem Connector

distractor). Repeat this step for the distal dual

diameter rod.

• Contour the 4.5 mm portion of the proximal dual

diameter rod to match the proximal end of the rod

template. Repeat this step for the 4.5 mm portion

of the distal dual diameter rod. The 5.5 portion of

the rod remains straight, as it will reside inside the

Extended Tandem Connector.

rod Template

FIGURE 4: Sizing and Contouring the rods

Tandem Connector/Dual Diameter rod Assembly

• Place rods into the anchors located above and below the Extended Tandem Connector. Assure that there is a 5 mm gap between the

two rods to allow for insertion of the distractor.

• Place the connector in the spine by inserting it onto the proximal and distal rods one at a time. Position the centre of the Extended

Tandem Connector about the centre of the gap between the rods.

Tandem Connector-revision

• To remove the Extended Tandem Connector in a revision case, loosen the proximal and distal set screws of the connector.

• Slide the Extended Tandem Connector proximally until the proximal end of the distal rod is no longer inside the connector. Move the

opening of the distal end of the connector away from the distal rod and slide the whole tandem connector off the proximal rod.

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roD roTATIon

The Extended Tandem Connector construct can be

used to facilitate a rod rotation maneuver by

replacing a full rod with a combination of one

Tandem Connector and two dual diameter rods.

With this construct, the proximal and distal dual

diameter rods can be rotated independently from

each other (Figure 5).

rotation of the First rod

• To rotate the proximal portion of the spine, first

loosen the Extended Tandem Connector’s proximal

set screw and then tighten the Extended Tandem

Connector’s distal set screws. Rotate the proximal

rod to the desired position.

• Tighten Extended Tandem Connector’s proximal

set screw and remaining proximal anchors to hold

the proximal rod in place. Set screws are not to be

tightened down until rod rotation has been

completed on the contralateral side.

• To rotate the distal portion of the spine, first

loosen the Extended Tandem Connector’s distal set

screw and then tighten the Extended Tandem

Connector’s proximal set screws. Rotate the distal

rod to the desired position.

• Tighten Extended Tandem Connector’s distal set

screw and anchors to hold the distal rod in place.

Set screws are not to be tightened down until rod

rotation has been completed on the contralateral

side.

rotation of the Second rod

• On the contra-lateral side, repeat steps above for

the second Extended Tandem Connector construct.

Long rod Dual rod-Proximal rotation

Dual rod-Distal rotation

FIGURE 5: Rod rotation

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InTrA-oPErATIvE CoMPrESSIon AnD DISTrACTIon

• The Extended Tandem Connector construct can be

used to facilitate intra-operative compression and/

or distraction maneuvers such as the ones that

occur after an osteotomy or a spondylectomy.

Below are the steps to follow:

• Loosen one or both set screws on the Extended

Tandem Connector. (Figure 6)

• If rod distraction is desired, insert the Tandem

Connector distractor into one of the channels of

the connector in order to separate the rods.

(Figure 7 & 8)

• If rod compression is desired loosen one or both

set screws on the Extended Tandem Connector

and place one tip of the compressor inside the slot

of the connector and the other tip against an

adjacent anchor and compress until the desired

correction is achieved.

• Tighten all set screws.

FIGURE 6: Distraction/Compression Maneuvers-Loosening Set Screw

FIGURE 7: Distracting the rod

FIGURE 8: Finalising Distraction & Tightening set screw

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4.5 System

4.5 System

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brIDgIng ProXIMAL AnD DISTAL roDS

The Extended Tandem Connector can be used

when the proximal and distal rods of the construct

need to be bridged as part of the correction

maneuvers (e.g., for wedge osteotomies or

vertebral column resection). In those cases, the

Extended Tandem Connector is used to give some

flexibility when estimating the correct rod lengths,

which is hard to gauge when the rods are not

collinear (Figure 9).

Anchor Insertion & Tandem Connector/Dual

Diameter rod Assembly

• Place anchors and rods per surgeon’s correction

technique. Leave the rods disengaged in the area

adjacent to the osteotomy until after the Tandem

Connector has been inserted.

FIGURE 9: Bridging proximal and distal rods after osteotomy procedure

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S U R G I C A L T E C H N I Q U E

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Sizing of the Extended Tandem Connector in

the Spine

Choose the size of the connectors that best fit the

anatomy and the area around the osteotomy

where the proximal and distal rods will connect.

Determining the size of the Tandem Connector

should be done once the correction maneuver is

completed and the proximal and distal rods are

parallel (collinear) to one another. It is important to

keep in mind that:

• The rods inside the connector should be long

enough so that the ends are visible through the

windows of the connector. If that is not the case, a

longer tandem connector will be needed (Figure

10)

• The rods should be short enough so that there is

at least a 5 mm gap between them to allow for

the insertion of the distractor (Figure 10).

• In the Coronal Plane, the Extended Tandem

Connector is located over the pedicles, between

the spinous process and the transverse processes

(as shown in Figure 2 on page 5).

• The connector is placed in the spine by inserting it

into the proximal and distal rods one at a time.

Position the centre of the Extended Tandem

Connector about the centre of the gap between

the rods.

Note: Anchors adjacent to the Tandem

Connector should be spaced apart no greater

than 76 mm for the 40 mm connector, 125 mm

for the 60 mm connector and 172 mm for the

80 mm connector.

Compression and Distraction Maneuvers

•Compression and/or distraction maneuvers can be

done as previously explained in this document.

Ends of the rods should be visible

FIGURE 10: Extended Tandem Connector placement after osteotomy procedure

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IndicationsThe EXPEDIUM Spine System is intended to provide immobilisation and stabilisation of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumour; pseudarthrosis; and failed previous fusion in skeletally mature patients.

Limited Warranty and Disclaimer DePuy Spine products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.

Not all products are currently available in all markets.

Distributed in the USA by:DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02767USATel: +1 (800) 227 6633Fax: +1 (800) 446 0234

Authorised European Representative:DePuy International LtdSt Anthony’s RoadLeeds LS11 8DTEnglandTel: +44 (0)113 387 7800Fax: +44 (0)113 387 7890

This publication is not intended for distribution in the USA.

DePuy Spine EMEA is a trading division of DePuy International Limited. Registered Office: St. Anthony’s Road, Leeds LS11 8DT, EnglandRegistered in England No. 3319712

EMEA: 9084-82-000 version 2 Issued: 03/12CA#7944

www.depuy.com

© DePuy Spine, Inc. 2012.All rights reserved.

*For recognised manufacturer, refer to product label.

Manufactured by one of the following:

DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02767-0350USA

DePuy Spine SÀRLChemin Blanc 36CH-2400 Le LocleSwitzerland

Medos International SÀRLChemin Blanc 38CH-2400 Le LocleSwitzerland